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Generated: September 22, 2017

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Title:Method for manufacturing allogeneic soft-tissue transplant having autologous stem cell transplanted therein
Abstract: Provided is a method of manufacturing an allogeneic soft-tissue transplant having autologous stem cells transplanted therein using an allogeneic soft-tissue support that is obtained from an allogeneic organism. In this regard, an allogeneic soft-tissue transplant that can replace a damaged soft-tissue of a human body is manufactured.
Inventor(s): Shim; Young Bock (Seoul, KR), Lee; Kwang Il (Anyang-si, KR), Jang; Ju Woong (Seoul, KR), Lee; Jung Soo (Suwon-si, KR)
Assignee: Cellumed Co., Ltd. (Seoul, KR)
Application Number:14/002,104
Patent Claims:1. A method of manufacturing an allogeneic soft-tissue transplant having autologous stem cells transplanted therein, the method comprising: obtaining an allogeneic soft-tissue support from a body of a human or an animal; washing and sterilizing the obtained allogeneic soft-tissue support; removing cells involved in an immunological rejection response by treating the washed and sterilized allogeneic soft-tissue support with an enzyme solution containing a mixture of trypsin, collagenase and protease; forming at least one pore in the allogeneic soft-tissue support by applying a superfine fiber needle to the allogeneic soft-tissue support treated with the enzyme solution and from which the cells involved in the immunological rejection response are removed; injecting autologous stem cells of a recipient into the at least one pore in the allogeneic soft-tissue support before or at a time of injecting an autologous stem cell loading promoter; and incubating the allogeneic soft-tissue support, into which the autologous stem cells are injected, to obtain an allogeneic soft-tissue transplant having autologous stem cells transplanted therein, wherein the allogeneic soft-tissue support is incubated by providing a physical stimulus to the allogeneic soft-tissue support.

2. The method of claim 1, wherein the allogeneic soft-tissue support is a ligament or a ligament connected to a bone fragment.

3. The method of claim 1, wherein the washing and sterilizing comprises treating the obtained allogeneic soft-tissue support with hydrogen peroxide and applying ultrasonic waves to the obtained allogeneic soft-tissue support.

4. The method of claim 3, wherein the hydrogen peroxide has a concentration in a range from about 0.1 to about 5.0% and the ultrasonic waves have an output in a range from about 120 to 400 watt.

5. The method of claim 1, wherein the washing and sterilizing comprises treating the obtained allogeneic soft-tissue support with a radioprotectant and irradiating the allogeneic soft-tissue support.

6. The method of claim 5, wherein the radioprotectant is cobalt-60 (Co.sup.60) and the irradiation is gamma ray irradiation in a range from about 12 to about 50 kilogray (kGy).

7. The method of claim 1, wherein the removing of the cells involved in immunological rejection response further comprises water washing the sterilized allogeneic soft-tissue support with physiological saline after being treated with the enzyme solution.

8. The method of claim 1, wherein the removing of cells involved in immunological rejection response further comprises an osmotic treatment with distilled water to wash the allogeneic soft-tissue support after water washing of the allogeneic soft-tissue support with the physiological saline after the treatment of the washed and sterilized allogeneic soft-tissue support with an enzyme solution.

9. The method of claim 1, wherein the forming at least one pore comprises a pore having a size in a range from about 1 to about 1,000 micrometer (.mu.m) range.

10. The method of claim 1, wherein the physical stimulus occurs at a frequency of less than 1 Hz.

11. The method of claim 1, wherein the providing a physical stimulus comprises providing tensile stress to two opposite distal ends of the allogeneic soft-tissue support, providing torsion to the allogeneic soft-tissue support in two opposite horizontal directions with respect to a vertical axis of the allogeneic soft-tissue support, or providing both tensile stress two opposite distal ends of the allogeneic soft-tissue support and torsion to the allogeneic soft-tissue support in two opposite horizontal directions with respect to a vertical axis of the allogeneic soft-tissue support, at the same time.

12. The method of claim 11, wherein the providing tensile stress to two opposite distal ends of the allogeneic soft-tissue support comprises extending the two opposite distal ends of the allogeneic soft-tissue support longitudinally, wherein one distal end is extended in a range of 0 to about 10% based on a total length of the allogeneic soft-tissue support and the other distal end is extended in a range of 0 to about 10% based on a total length of the allogeneic soft-tissue support, at the same time.

13. The method of claim 11, wherein the providing torsion to the allogeneic soft-tissue support in two opposite horizontal directions along a vertical axis of the allogeneic soft-tissue support comprises rotating the two opposite distal ends of the allogeneic soft-tissue support, wherein one distal end is rotated in a range of 0 to about 45 degrees clockwise and the other distal end is rotated in a range of 0 to about 45 degrees counterclockwise, at the same time.

14. The method of claim 1, wherein the incubating is performed for less than 7 days.

15. The method of claim 1, wherein the stem cell loading promoter is a collagen gel.

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Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
South Korea10-2011-0018216Feb 28, 2011
South Korea10-2012-0018650Feb 23, 2012
PCT Information
PCT FiledFebruary 24, 2012PCT Application Number:PCT/KR2012/001443
PCT Publication Date:September 07, 2012PCT Publication Number: WO2012/118305

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Inventors Patent Expiration Status Orphan Source
Advance Biofactures
SANTYL
collagenase
VIAL1019950011965-06-04► Subscribe Cellumed Co., Ltd. (Seoul, KR) Shim; Young Bock (Seoul, KR), Lee; Kwang Il (Anyang-si, KR), Jang; Ju Woong (Seoul, KR), Lee; Jung Soo (Suwon-si, KR) ► SubscribeRXsearch
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International Patent Family for Patent: ► Subscribe

Country Document Number Publication Date
South Korea101352378Feb 03, 2014
South Korea20120100748Sep 12, 2012
United States of America2015209476Jul 30, 2015
World Intellectual Property Organization (WIPO)2012118305Dec 20, 2012
World Intellectual Property Organization (WIPO)2012118305Sep 07, 2012
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Serving 500+ biopharmaceutical companies globally:

Fuji
Harvard Business School
Medtronic
Johnson and Johnson
Julphar
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Chinese Patent Office
Boehringer Ingelheim

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